Nexgen Pharma Inc – FDA EIR, Jan 31, 2020

Nexgen Pharma Inc. underwent a pre-approval and routine surveillance FDA inspection from January 27-31, 2020, at its Irvine, CA facility. This inspection, conducted under Compliance Programs 7346.832 and 7356.002, confirmed the company's adherence to the Food, Drug and Cosmetic Act. A significant finding was the successful remediation of six official action indicated (OAI) observations from a previous inspection in October 2017. These prior issues had included deficiencies in equipment design, documentation of packaging and labeling inspections, investigation of batch failures, quality control unit responsibilities, laboratory controls, and warehousing procedures.

During the current inspection, no new FDA 483, Inspectional Observations, were issued. Minor observations included a washroom sink lacking hot water, which was promptly corrected during the inspection. A data integrity concern arose regarding analytical balances lacking controlled date and time functions; however, IT personnel addressed this, and the firm committed to implementing necessary access controls. Additionally, an out-of-tolerance water quality test for a laboratory water unit was noted, prompting the firm's decision to discontinue its use. While regulatory warning statements regarding potential legal and advisory sanctions were provided, these are standard and not indicative of new formal violations for this particular inspection. The inspection concluded without samples collected or refusals, and the company's drug registration remains current.